Method and Devices for Treating Obesity, Incontinence, and Neurological and Physiological Disorders

ABSTRACT

Methods and devices are disclosed that provide therapeutic benefit and treatment for a variety of neurologic and physiologic conditions that include obesity, urinary incontinence, and sensory system disorders.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/010,863, filed Jan. 29, 2016, incorporated by reference in itsentirety herein. U.S. application Ser. No. 15/010,863 is a continuationof U.S. application Ser. No. 11/986,939, filed Nov. 26, 2007, which is acontinuation-in-part of U.S. application Ser. No. 09/457,971, filed Dec.9, 1999, and now U.S. Pat. No. 6,375,666; U.S. application Ser. No.10/056,323, filed Jan. 24, 2002, now U.S. Pat. No. 6,764,498; U.S.application Ser. No. 10/843,828, filed on May 11, 2004; and U.S.application Ser. No. 11/602,714, filed on Nov. 21, 2006, U.S.application Ser. No. 11/504,514, filed on Aug. 14, 2006. In addition,this application claims the benefit of, and incorporates by referencethe following applications: provisional application with Ser. No.60/727,446, filed on Oct. 17, 2005, provisional application Ser. No.60/708,357, filed on Aug. 15, 2005, provisional application Ser. No.60/738,892, filed Nov. 22, 2005, and provisional Ser. No. 60/171,687,filed on Dec. 21, 1999, utility application Ser. No. 09/733,775, filedon Dec. 8, 2000, and utility application Ser. No. 09/444,273, filed onNov. 19, 1999, and provisional application Ser. Nos. 60/169,778;60/181,651; 60/191,664; 60/181,445, 60/171,760 and 60/183,706.

FIELD OF INVENTION

The present invention relates generally to the modification ofelectrical conduction properties within the body for therapeuticpurposes. The device and methods are disclosed in the context oftreating neurological and physiological disorders that affect a varietyof anatomical organs and tissues.

BACKGROUND OF THE INVENTION

The current methods of treating a range of neurological andphysiological disorders include the use of systemic drugs, surgicalprocedures, tissue ablation, electrical stimulation and gene treatments.Many of these disorders are manifested by gross conduction defects ornervous system dysfunction. These neurological disorders are may affectmany types of anatomical organs and tissues such as brain, heart,muscle, nerves and organ tissues.

SUMMARY

In contrast to the prior art, the present invention proposes treatmentof neurological disorders by subjecting selected tissues to localizedmechanical stress. It is difficult to quantify the level of stressapplied to the tissue; operable values will vary from low levels to highlevels dependent on the type and location of tissue to be treated. Thetissues treated can be of many types within the body such as the brain,heart, muscles, nerves or organs.

The invention is disclosed in the context of neurological disorders butother the inventive technology can also be used to treat a wide varietyof organs and anatomical tissues, and the treatments of other types ofailments are contemplated as well.

For example, other applications of this invention include placement inthe pituitary, thyroid, and adrenal glands or in a variety of organs. Inaddition, placement of the inventive device in tumors may suppressgrowth due to nerve and vascular compression. The later may preventblood-born metastasis to other parts of the body. Likewise, hemorrhagingcan be stopped or reduced by vascular compression using the invention.Pain management in all parts of the body can be achieved by placement ofthe inventive device adjacent to selected nerves. Positioning aninventive stress-inducing device within the bone can accelerate healingof broken bones. Disclosure of this invention for neurological andneuromuscular applications is intended to be illustrative and notlimiting.

In the treatment of treating cardiac arrhythmias, sometimes the resultof a neuromuscular disorder, the inventive device can be positionedwithin, on, through, or adjacent to heart tissue in order to affect orblock electrical conductions that cause symptoms such as atrialfibrillation, pacing defects, hypotension and hypertension. Theinventive devices and methods can replace the current practice of RFablation, surgical procedures (such as the Maze procedure) andanti-arrhythmia drugs.

Proper shape, geometry, and placement of the devices can result intreating the tissue in a similar shape and fashion as those in theaforementioned treatments. The shape of the treatment of the typicalMaze procedure can be replicated with the proper physical shape andplacement of the inventive device. One embodiment of a device for amethod of treating cardiac arrhythmia is a device similar to a rivet.The first end of the rivet would pass through the desired location ofthe myocardium and be positioned or seated on the external or internalsurface, depending on approach. The second end of the rivet combinationwould be slid along the shaft of the rivet and seated on the oppositeside of the myocardium as the first end of the rivet. The first andsecond end would then be advance towards each other resulting incompression, elongation or mechanical stressing of the myocardial tissuebetween and proximate to the rivet. The amount of mechanical stressingwould be controlled by the distance form the first end to the secondend.

The inventive devices and methods can be used in the treatment ofcardiomyopathy. A primary cause of cardiomyopathy is a lack of theproteins dystrophin and collagen, the same protein deficiency thatexists in the skeletal muscles and leads to generalized weakness,wasting and respiratory complications. Dystrophin and collagen is alsoneeded by cardiac muscle, and its lack can lead to the loss of cardiacmuscle cells under the stress of constant contraction. It is know thatmechanical forces on tissues can generate increased deposition ofcollagen fibers within muscular tissues and strengthen these tissues. Inthe treatment of cardiomyopathy, the inventive devices can providemethods of selectively, broadly or focally, generating mechanicalstresses that result in the therapeutic deposition or increasedformation of collagen fibers. These fibers can then strengthenmyocardial tissues muscle and retard or reversing the effects ofcardiomyopathy. This phenomenon can also be used to treat other diseasesand illnesses that affect tissue strength and connective tissueorientation, density and volume. In addition, the deposition orformation of collagen in a predetermined formation or matrix can allowof nerve growth along the collagen fibers. This can be useful in formingcircuitry for heart conduction pathways as well as the growth of newnerves to treat spinal injuries or paralysis.

Many neurological disorders are a result of improper conduction ofelectrical currents in various brain tissues. In the case of Parkinson'sdisease, the conduction currents in the thalamus tissues becomedisorganized and cause conditions associated with the disease. Likewise,in epilepsy errant currents cause various levels of seizures. In casesof dystonia, errant currents originate in the basal ganglia. Depressionand schizophrenia are associated with various electrochemical defects inother portions of the brain. Also, pain symptoms such as trigeminalneuralgia are associated with multiple sclerosis. Paralysis is normallya condition that results from brain injury, nerve damage, or nervesevering.

The localized stresses generated by the inventive device called aMechanical Stress Device (MSD), will control, inhibit and direct currentconduction by reorienting and/or reorganizing the electrical bias of theneurological tissues. In addition, applications for the MSD includecompression of selected nerves in order to control, mediate, or suppressconduction along the nerve fibers and bundles that are associated withcertain neurologic disorders. The localized stresses also can affectactivate or suppress baroreceptors within arteries, veins, heart tissueand other tissues and organs. Affecting the baroreceptors can allowcontrol of various physiologic functions such as sinus rhythm,sympathetic nervous system, blood pressure, hormonal activity andmetabolism as examples. The inventive devices and methods can affect thewall of the carotid sinus, a structure at the bifurcation of the commoncarotid arteries. This tissue contains stretch receptors that aresensitive to mechanical and electrical forces. These receptors sendsignals via the carotid sinus nerve to the brain, which in turnregulates the cardiovascular system to maintain normal blood pressure.The proper method of use and placement of the inventive device canmanipulate the baroreceptors and achieve regulation of thecardiovascular system in order to control blood pressure levels. Forexample, when place proximate to the carotid sinus, the MSD will applylocalized stresses that modify or modulate the stretch baroreceptors.The MSD can be complemented with electrical properties and features thatcan provide additional affects to the baroreceptors function.

The MSD can be placed internal or external to arteries and veins inorder to achieve desired activation of baroreceptors. MSD can beattached to external body plane; skin.

The MSD can also be utilized as an electrically conductive device thatcreates an electrical connection or “bridge” between targeted anatomicaltissues. This technique may facilitate tissue-to-tissue communication,aid in regenerating nerve connections, or affect the electricalconduction between the SA and AV nodes of the heart to overcome pacingdefects. Likewise, an MSD may be placed proximate to the pulmonary veinin order to quell, block or mitigate abhorrent conduction currents thatcause atrial fibrillation.

In the case of Parkinson's disease, an MSD is implanted in the tissuesproximate to the thalamus and induce localized stresses that causedepolarization of the thalamus tissue and thus eliminate or reduce thesymptoms of the disease. In Dystonia, the MSD is positioned proximatelyto the basal ganglia and disrupts the electrical disturbances associatedwith this disorder.

The same effect is utilized in the treatment of epilepsy and othertissues when the MSD is installed in the targeted brain tissues. An MSDmay be place on or adjacent to the vagus nerve in order to mechanicallyand or electrically cause stimulation. This stimulation of the vagusnerve can provide therapeutic treatment of epilepsy and depression. Inaddition, MSD stimulation of the vagal nerve can provide treatment forheart function such as cardiac ventricular output, rhythm, and systemicblood pressure. The devices and methods associated with the MSD can alsobe utilized in the sinuses and various ventricles of the brain to treatpersonality disorders such as schizophrenia or depression. Additionally,migraine headaches and Tourette's Syndrome may be treated with the MSDtechnology. In general, the methods of the invention guide the placementof the device to ensure a therapeutic effect from the device.

In another application, Vestibular disorders, which may interact withblood pressure and heart rate control, can be treated and controlled.The vestibular system is one source of information about uprightness andthe system has an affect on the cardiovascular system. Proper placementand manipulation of the vestibular nerve with one or more of the MSDdesign embodiments can alleviate or control heart rate and bloodpressure, as well as physical balance.

The MSD technology may also be used to affect the neurologic response ofthe digestive system in order to control appetite, digestion ormetabolism. In addition, using the previously invented methods anddevices in this and the cross referenced patent and applications byMische, the MSD technology can be used to treat urge or stressincontinence by affecting nerve conduction and neuromuscular function.Also, the neurological and neuromuscular function of the reproductivesystem can be treated and controlled by using the MSD technology tomodify transport and expression of hormones, sperm, ovum, and fluids.

The MSD can be permanently implanted or used acutely and then removed.Likewise, the device can be fabricated of biodegradable materials thatare placed chronically and allowed to biodegrade over time.

The devices and methods can be used alone of in conjunction with othertherapies.

Examples of electrical therapy with various MSD embodiments are givenand they include pacing, depolarization, ablation, and tissuealteration.

MSD devices can be configured so that they deliver treatment on atemporary basis and are then removed or disabled. For example, a devicesuch as in FIG. 7 could be used for a temporary treatment regimen ormethod. The device would be deployed, positioned, expanded for a periodof time and then retracted and removed when desired. It could also beused in conjunction with an electrical stimulator. In anotherembodiment, the device could be a balloon construction that is inflatedfor the treatment period and then deflated and removed. Additionally,the balloon construction could also have one or an array of electrodeson the surface, as well be made of electrically conductive polymers. Thetreatment regimen would cease when desired, or if undesired clinicalresults are observed. The long term result could be attained when thetissues which caused the negative illness state were “retrained” by theMSD type device and further treatment would not be necessary.Additionally, physical remodeling of the tissue may be the result of atemporary treatment regimen.

In some therapeutic cases it may be beneficial to treat in a method thatallows the MSD to be placed at the treatment site and the deliverysystem is left engaged for a period of time. This period of time couldbe used to observe, measure the effectiveness of the treatment and/orallow a modification to the treatment parameters during this period oftime.

MSD devices can be configured so that upon delivery to the desiredlocation within the tissue or body, they are detached from the deliverydevice by unscrewing, detent release, release of compression oradhesive, or release of other means of securing the MSD to the deliverydevice. Other means of securing the MSD to the delivery device includesforceps, graspers, swaging, jamming, wedging, friction, tying,magnetics, electrical discharge, melting, fusing, defusing, grapples,etc.

MSD devices can be configured so as to release a therapeutic substanceor drug when activated by external or in situ mechanical, chemical orelectrical stimuli. These stimuli can actually be provided anddistributed by the treated/malfunctioning tissues or tissues proximateto the treated/malfunctioning tissue. The stimuli can be provided by thetissue from localized spasms originating from tissue, muscle or organs,as well as abhorrent electrical signals or biochemical release generatedby the diseased/affected tissues. Delivery of the therapeutic substancescould continue until the tissues are inactivated and associated symptomsare thus relieved.

In some clinical cases, it may be necessary to contract a volume oftissues. Instead of a device being therapeutic in its expansive state,it may also provide therapy during volumetric contraction. One examplecould be a device, similar to FIG. 7, with grapples or hooks that areplaced within a brain ventricle. Upon activation, the device could grabthe walls of the ventricle and collapse or contract volumetrically.Another embodiment would be a device that is expanded in order to grasptissue and then retracted to contract, elongate or stretch the tissue ina predetermined direction and stress strain parameters. This inventioncould be used in other types of ventricles, cavities or openings. Thiscan also be used in solid tissues, bones, and organs. MSD technology canbe used to expand ventricles and ducts within brain tissues and organsso as to improve drainage of fluids, relief of tissue-to-tissueinterface, and to relieve or improve physiologic pressures within aventricle, or between a ventricle or duct. For example, an expandableMSD can provide a device technology and a treatment method for openingbrain ducts and draining excess CSF from the brain.

MSD's can provide a form of mechanical dilatation of tissue. Means ofcreating tissue dilatation include dilator tools that are on a shaftwith the treatment end having physical features that can be one or moreof the following: diametrically tapered, rounded, blunt, inverted, orexpansive.

MSD's can provide a substrate for carrying neurons or other biologiccompositions. These types of devices can also be used to treat manyother types of neurologic or physiologic disorders.

MSD's can use their inherent geometries to prevent migration afterplacement at the treatment site. Additionally, complementary featurescan be incorporated to the device so that they do not migrate afterplacement. These complementary features can include spikes, hooks,sutures, bumps, voids, threads, barbs, inverted wedges, filaments,coarse surfaces, adhesives, etc.

MSD's can be constructed so as to be affected by the change intemperature of the tissues proximate to the treatment sites. In somecases, these temperatures may be a result of abhorrent electricalsignals, chemical response or mechanical forces within the tissuesproximate of the treatment site. When the temperature changes, thephysical properties of the MSD changes, as well as the affects of to thebrain (i.e., localized stresses and strains). This can be accomplishedby the use of temperature sensitive materials such as Nitinol orbi-metallic structures. Other embodiments may use polymers and metalswhich change shape when affected by electrical, chemical, light, ormechanical energy.

An MSD can be controlled utilizing thermally, pneumatically, or withmagnetostrictive properties of the construct.

An expandable preformed MSD can be shaped appropriately (i.e.,trapezoid, rectangular, tubular, conical, curved, etc) in order to biasthe therapeutic stresses to tissues and avoid imparting stressed totissues. A MSD's expansion can be controlled by magnetic coupling to ajack, screw or ratcheting mechanism. An external magnet outside of thebody would be manipulated to cause an interaction with the implantedMSD. The external magnet may spin and, via coupling, cause a screw toturn and effect the sizing of the MSD, modifying the stresses impartedto the tissue. Likewise, a miniature motor assembly in the MSD can beused to drive the expansion or contraction of the MSD. The expansion andcontraction can be modulated one-time, many times over a period, or at arepetitive frequency that causes sustained or short term vibrations. Themotor can be operated by an implantable battery system, utilize ahardwire connection to a generator, coupled inductively or capacitively,or magnetically It has been shown that stress to tissues can result inlocalized increase of collagen deposits. These collagen deposits canimprove tissue strength as well as create a matrix for nerveregeneration. The orientation of stresses created by the MSD devices canpredetermine the deposition of collagen and nerves.

This phenomena can be use to reconnect severed nerves or reroute nervesand electrical conduction pathways within tissues such as the brain andheart.

MSD can physically, biologically, mechanically, chemically orelectrically modify production of detrimental biochemical/brainchemistry such as dynorphin or a chemical in the brain called CREB orcyclic AMP responsive element binding protein, which can causedepression, anxiety or other maladies. Biological and chemical additivesto the MSD can scavenge or modify detrimental biochemical/brainchemistry such as dynorphin that can cause depression or other maladies.Likewise, MSD's can modify the action potential of the brain cellularmake-up by reversal of the electrical potential in the plasma membraneof a neuron that occurs when a nerve cell is stimulated; by changing themembrane permeability to sodium and potassium.

MSD technology in the form of a balloon can provide a number of designalternatives and treatment methodologies. For example, a balloon thatconforms to the cortical surface of the brain can provided constant orvariable localized stresses that provide therapy. The balloon surfacecould be smooth or flat, or could have projections or bumps that contactthe brain tissue in a predetermined fashion. This allows for distinctand focal stresses and strains on brain tissue. The MSD balloon can becontrolled by the connection to an implantable pump mechanism. The pumpregulates the expansion and deflation of the balloon in order tocustomize the size and shape of the balloon. This allows for varyinglevels of stress to the tissue. The pump can be controlled by a wirelessremote control via the likes of inductive coupling, RF or Digitalcommunications, etc. Also, the pump could be controlled by hardwireconnection to a control module. The pump could be controlled by healthcare personnel or by the patient. A balloon can be shaped appropriately(i.e., trapezoid, rectangular, tubular, conical, curved, etc) in orderto bias the therapeutic stresses to tissues and avoid imparting stressedto tissues.

An MSD can be placed anywhere in the body so that it impacts neurologictissues and provides therapy. These areas include Area 25 in the brainto aid in treating depression. A MSD can be placed proximate the pudenalnerve to treat incontinence.

All MSD designs can be positioned within tissues in a remote locationfrom the region where an abhorrent signal is originating. In this case,the MSD can interrupt a signal pathway, circuit, or transmission line.For example, an MSD can be placed on the cortical surface of the brain.Placement and stress applied in the proper location can treat/control anumber of physiologic functions (i.e., atrial fibrillation, pain,incontinence, blood pressure, hormonal activity, etc). For example,proper placement on the cortical surface can help treat Parkinson'stremors by interrupting or modifying the corto-basal ganglia motorcontrol loop. An MSD may be formed in a Cartesian coordinate fashion soas to be able to program the affect to the tissue in the most desirablefashion.

A MSD can be positioned on the spinal column, spinal nerve or vertebralnerves to block or dissipate abhorrent signals and/or pain in remoteregions of the body.

An MSD can be used to treat sciatica by placement directly on thesciatic nerve or in the spinal column nerve bundle. Likewise, scoliosismay be treated by selective treatment of nerves and/or nerve bundleswith a MED. Additionally, an MSD can provide treatment of atrialfibrillation by placing a MSD in the proper location of the spinalnerve/bundle column to control the fibrillations A MSD in the form of anexpandable Deep Brain Stimulator (DBS) lead can be used to applycontrolled stresses, record EEG and other parameters, connect togenerator for stimulus. These actions can be done simultaneously,sequentially, or in an order determined by the operator. A MSD in theform of a DBS lead can be used temporarily or implanted permanently. Theexpansion of the MSD at the tip of the lead can be controlled at theproximal end of the lead by pulling, pushing, twisting, sliding, andmechanisms. The sizing of a MSD can be controlled by power orinformation provided by a DBS or electrical generator. A separate“communication” channel can be used to send signals or power to the MSDthat dictate the expansion, contraction or vibration of the MSD. Thegenerator/MSD configuration would thus provide the ability to treat thepatient with complementary effects. An MSD can be configured in such afashion so as to accept or “dock” with a standard DBS lead. Likewise, itcan be configured so as be disengaged or “undocked”.

MSD's that pinch neurologic tissues (brain, connective tissues, nerves,muscles, organs, etc) alter the electrical and/or chemical properties.This phenomenon is useful in treating disorders. MSD's can be implantedthat electrically or chemically neutralize tissue to treat disorders.The tissues electrical potential can be “grounded” to dissipate theabhorrent signals. The tissues chemical potential can be changed byaffecting the pH of certain regions by inserting chemicals, drugs, orelements that modify these regions pH. These substances can be insertedalone or be part of a complex treatment regimen or on a device(permanent implant or temporary implant). An MSD device can also beuseful in suppressing or deterring the formation of lesions associatedwith multiple sclerosis.

The MSD can be a partial or complete band or hoop that goes on or arounda portion of the brain or the entire circumference. The MSD may beactivated manually through the skull by having a portion of the MSDprotruding from the skull bone that is manually activated by the patientor medical personnel. The manually activated portion can be under thescalp or protrude from the scalp.

A MSD can be used to treat ulcer (stomach, intestinal, diabetic, etc)when placed proximate an ulcer and cutting off blood flow and neurologicactivity. The MSD can be placed endoscopically or angiographically ifneeded.

An MSD electrode can be made with moveable sheath that allows controlledexposure of one or more electrode elements as necessary. Exposure mayoccur by the projection or expansion of the electrode element(s) in aradially, axial, or longitudinal fashion. Electrode construction withmultiple barbs that project in a racially and/or longitudinal or axialdirection. If desired, barbs/projections can be electrically andmechanically independent from each other. An MSD electrode with amoveable sheath will provide variable exposure and expansion ofelectrode element. An MSD electrode can be made so that the operableportion is biased in a predetermined radial direction from the axis. Theradial direction can encompass from 0 to 360 degrees. In alternativeembodiments, there may be a number of elements that are independentlycontrollable in order to customize the electrodes projections andeffects.

As discussed in the previously in the applications and patents by Mischeand Mische et al that this application claims the benefit of andincorporates by reference, the MSD technology application can be used totreat a number of physiologic disorders and provide therapeutic methodsfor syndromes. These previous applications and patents teach one skilledin the art the following methods and devices which are being claimed.

Urinary Disorders

One particular application is in the treatment of urinary disorders suchas urge urinary incontinence, hyperreflexia of detrusor (over-activebladder), and vesical-sphincter dyssynergia as examples. Urgeincontinence is associated with persistent sensation that the personneeds to urinate. It causes much discomfort and anxiety for thesufferer. Current treatment regimens include the implantation ofneurostimulation devices that connect to the sacral nerve via anelectrode, surgical nerve disconnect, drugs, botox injections andcapsaicin injections. All of these current treatments result in theprevention or blockage of signal transmission between the bladder nervesand the brain. The neurostimulators create a nerve block that preventsthe urge sensation from being transmitted to the brain. One of theproblems with the neurostimulator technology is the price, componentreliability, electrode failure, battery life, and the implantation of anlarge electrical generator. Treatments with agents and drugs are notusually a permanent solution. Cutting nerves (e.g. vagotomy) ispermanent. The MSD technology can provide an effective nerve block bycreating a total or partial mechanical nerve block when placed proximateto the sacral nerve. The block occurs when the MSD imparts createslocalized or direct mechanical stress, strain or forces on the targetnerve or innervation zone. The mechanical force can result when thenerve or innervation zone is compressed, expanded, elongated asexamples. The implantation method can be surgical or endoscopically.Other urinary bladder disorders that may be treated with the inventivemethod and devices include non-obstructive urinary retention andurgency-frequency. In a preferred procedural embodiment, the MSD wouldbe place adjacent, around, or within the sacral nerve sheath or nervebundle. The procedural method would preferably include a test sequencein order to identify the appropriate nerve site.

A test stimulation can be applied to the site with electricalstimulation via an electrode or with mechanical stimulation. The deviceused for test stimulation may in fact be the MSD or a portion of theMSD. When the physician identifies the nerve site, an MSD can then beadvanced to the site. An MSD that has an adjustable physical profile canthen be either adjusted or left in place for future adjustment. Aspreviously disclosed in the applications and patents that this patentclaims benefit to, the MSD may be connected to an electrical generator,incorporate an electrical generator, or be activated by an externalelectrical generator. For one skilled in the art, it is apparent thatother forms of activation or complementary therapies and technologiescan be implemented with the MSD and are also incorporated by referenceand claim benefit of the previously disclosed applications and patents.The sacral nerve can be accessed near the sacrum either surgically orpreferably percutaneously. Sympathetic nerve fibers coming from thehypogastric plexus of nerves or parasympathetic nerves traveling to thebladder with pelvic splanchnic nerves can also be directly affectedwithin the body or near the bladder with surgical techniques or withminimally invasive methods such as laparoscopy. The MSD can be implantedthrough a needle, catheter or cannula. The MSD can be in many forms aspreviously described. The MSD may impinge, pinch, clamp, wrap, stretch,elongate, compact, or compress the nerve. The MSD fashioned frombiodegradable, bioerodable, or absorbable materials can provide for apredetermined treatment time-frame. This may allow for the “retraining”or “reprogramming” of tissues, organs or the neurologic system andnegate or reduce the need for further therapy. The MSD technology mayalso be used by placing the MSD directly into the bladder and expandingit. The stresses imparted to the bladder wall affects the bladderinnervation and relives symptoms of urge and the affects of diseasessuch as interstitial cystitis. The MSD may be place surgically orintroduced through the urethra or through the ureters. The affects maybe similar to the outcomes of hydrodistension of the bladder, althoughthe results would last as long as the MSD device is left in the bladder.The MSD for this application can be self-expanding or expanded with adevice such as a balloon catheter. The MSD could be further activated byheat, electrical energy, or other methods discussed previous, in ordercontrol the expansion or contraction of the device as needed. The MSDcould also be applied or wrapped around the outer surface of thebladder.

Eating Disorders

Another embodiment includes the treatment of eating disorders such asobesity and bulimia. In the treatment of obesity, the stomach triggershunger pangs that are transmitted to the brain telling the person toeat. When the stomach transmits these signals too often, the person eatsto often and thus gains weight due to the over consumption of food.Current treatments include stomach surgery to reduce its volume andneurostimulators that stimulate the vagal nerve. In this type oftherapy, the neurostimulators again are providing treatment by causing anerve block. The implant procedure again requires surgery and theimplantation of an expensive electrical generator.

The MSD technology can provide an effective nerve block by creating amechanical nerve block, or down-regulation of the neural activity, whenplaced proximate to the vagal nerve near the stomach or other organ ofthe gastrointestinal tract. If so desired, the forces applied to thenerve can be adjusted or predetermined in order to selectively affectthe afferent and efferent nerve activity, as well at to generally affectthe nerve synapses, neurotransmitters, mechanosensory properties as wellas specifically affect the nerves homotropic and heterotropic modulationcharacteristics. It should be noted that the splanchnic nerve, orsplanchnic nerves, may also be the target nerve for MSD application inthe treatment of obesity. Therefore, it should be understood by oneskilled in the art that the MSD inventions, methods, and devices can beutilized to provide beneficial therapy my manipulation of the splanchnicnerve or other nerves. In fact, the vagal, splanchnic nerve, or othernerves may be targeted at the same time for a combinatory result.Likewise, the celiac ganglia may also be targeted.

The MSD implantation method can be performed surgically or withminimally invasive procedures such as endoscopically or laproscopically.Although the following describes treating a vagal nerve with an MSD, itis also intended to illustrate the use for other nerve-targetapplication. In the endoscopic embodiment, the doctor would use many ofthe same tools to perform the MSD implantation that are currently usedfor endoscopic procedures. In one embodiment, the doctor would utilize asystem comprising of an endoscope and a trocar or hollow needle thatpierces the nerve bundle. Once the needle has penetrated the covering,the MSD is then advanced through the needle and proximate the vagalnerve, or within the vagal nerve bundle. Likewise, it can be placedwithin or adjacent to the nerve and vascular sheaths. It can also beimplanted on or within the organs, muscle, and vascular system. The MSDcan be a solid, static device that fills a volume or an expandabledevice. In either case, the MSD imparts mechanical stress to the nerveand results in a blocking of nerve transmission. One or more MSD's canbe positioned at varying intervals along or proximate to the nerve. TheMSD can have means to anchor in place, Such means can be barbs or tines,The MSD can be connected to an electrical generator or drug pump inorder to get complementary therapeutic responses. As previouslydiscussed, the MSD can be in the form of an inflatable balloon thatcompresses, impinges or stretches nerves in order to create nerve blockor down-regulation. The balloon can be made of an elastomeric or anon-compliant material. An elastomeric balloon would allow for varyinggeometries as the amount of inflation media is injected. Also, theballoon can be readily adjusted as needed to vary the treatment level.As discussed previously, the balloon can be controlled by an internal orexternal pump. The balloon can also be placed and operated within thegastrointestinal tract. The balloon may also be in a tubular form so asto allow passage of food, fluid and particles through the digestivetract. The MSD can also take place as injectables such a slurry, paste,gel, liquid, foam, or dispersions that are injected within or around thenerve bundles. The injectables can also be loaded with other substancessuch as Botox, anesthetics (e.g. lidocaine), stimulants, irritants, orother substances that can aid in blocking the nerve conduction. Aspreviously mentioned, the MSD can be made of a biodegradable materialthat degrades over a prescribe time in order to regulate the time periodthat the nerve is blocked or down-regulated, and thus regulate the timeperiod of treatment. This inventive method of treatment allows for atherapeutic time-frame that is a function of the biodegradable rate ofthe MSD. For the sufferers of obesity, the therapeutic timeframe may beof length so that the patient loses a sufficient and healthy amount ofweight. This may allow for the person to regain an active and healthylifestyle that may aid in maintaining a healthy body mass. In anotherembodiment, the MSD may provide a partial block of vagal nerve functionso that the intensity of the nerve signals is reduced. This may minimizethe level of hunger that the person experiences thus they may not ingestas much food.

In another embodiment, the method of treatment would include an MSD thatis implanted on the stomach and proximate to the vagal nerve. As thestomach expands with food intake, the MSD in pushed, pressed, compressesor elongates the vagal nerve so as to affect the block the conduction,or block, of the nerve. An MSD can be in the form of a “Chinesefinger-lock”, a braided-tubular structure. This type of structuredecreases in diameter as its ends are pulled apart, and expands indiameter as the ends or pushed together. It can then be placed aroundthe vagal nerve on the surface of the stomach and fixated at both ends.As the stomach fills with food and expands, the ends of the MSDstructure move apart and its tubular diameter decreases. As it decreasesin diameter, the MSD compresses the nerve, creates a nerve block, andsubsequently the person feels hunger satiate and reduces or stopseating. This structure can also be made in a scale large enough to fitover a portion of the entire stomach. Again, as the person eats and thestomach fills, the can compress or restrict the stomach and causesatiety of hunger. Using the expansive properties of this type fortherapeutic purposes allows it to be placed within an organ such as onthe internal wall of the stomach. If the device is attached to thestomach wall, it will expand as a function of the stomachs expansion asfood is ingested. Therefore, as the stomach expands, the device expandsand exerts force on and through the stomach lining and affecting theinnervation of the stomach. This will cause mechanical nerve blocks andprovide a sense of satiety to the patient. Again, this device can bemade of materials that are biodegradable, bioerodable or digestible sothat the therapy is not permanent. The remnants can be pass through theintestinal tract or defecated. Selecting the appropriate materials willallow a for a predetermined treatment timeline. This device can beinserted within the stomach surgically, gastropically, endoscopically orswallowed by the patient. In the embodiment where the device isswallowed, the expanding MSD can be compacted and coated with arestricting material, formed into a pill or inserted into a pillcapsule. Upon residing in the stomach, the device would deploy when thecoating, pill or capsule disintegrate in the environs of the stomach. Asit expands, it conforms to the stomach form. It may be important to havethe patient drink enough fluid to expand the stomach prior to swallowingthe MSD. Magnetic materials may be a component of the MSD so as tointeract with a magnetic device in order to provide the ability toproperly orient the swallowed MSD within the stomach. He magnetic devicecan be operated outside or inside the stomach. The swallowed MSD mayalso be of the form of a compressed foam material that expands whenreleased. The foam material could be swallowed in similar formats ordelivered by other aforementioned methods. As the foam form expands, itwould fill a predetermined volume of the stomach and limit food intake,as well as providing down-regulation or nerve blocking of the stomachsvagal innervation as it provides mechanical stresses as it expands. Theexpanding foam material could actually be taken as a supplement beforeor during meals. In a preferred embodiment, the material could bebiodegradable or digestible so that it is not permanently installed. Itcan follow the digestion schedule of co-ingested food and pass throughthe intestinal tract with the digested food. The foam material can alsohave nutritional supplements, medicines, or diagnostic materials ascomponents. Medicines within the foam MSD can be beneficial to locallydelivery therapy to stomach ulcers or other alimentary organ maladies.The foam material may be composed of cellulose bases or other materials.The foam MSD may expand or swell when chemically activated by thegastric fluids within the stomach. Another embodiment can use the foamas substantially tubular form that approximates a lining of the stomach.The thickness of this lining can be predetermined. It may also be formedin situ using a delivery system that injects a form around a balloonthat is inserted within the stomach. The balloon is then collapsedleaving the formed lining in place. Other methods and devices may beused to create this lining without departing from the inventive intent.This type of lining may also be used to treat nasal sinus disorderswhile maintaining air flow or to bridge anastomosis (connection) ofvarious organs and biologic conduits. Although the use of the expandingfoam MSD form has been discussed for use within the stomach, it isapparent to one skilled in the art and technology that is cal be used toprovide treatment to other body organs, orifices, and physiology. It canbe inserted or injected in, on or near selected nerves, blood vessels,tracts (i.e, urinary, reproductive, digestive tracts) and biologicstructures. Alternative geometries, structure, materials and designs canalso be implemented designed in order to achieve similar outcomes. Forexample, expanded Teflon, similar to that used for vascular grafts, canbe used to achieve similar results. Metals, polymers, fabrics,balloon-structures, or combinations of these can be used. The MSD canalso be a dissolvable or metabolizable substance or material. The MSDtechnology can also be used to treat the over-production of acids withinthe stomach by affecting the conduction of the vagal nerve structure.Too much stomach acid causes ulcers and stomach irritations. In all thecases, the procedure can actually be done in a minimally invasivefashion by accessing the vagal nerve from within the stomach. In thiscase, gastroscopy could be utilized to access the interior stomach andidentify the proper location of the vagal nerve. Once located, the MSDcould be advanced in to, or through the stomach, and proximate to thevagal nerve. MSD designs such as a clip, a suture or a loop couldembrace and compress the nerve. This method and devices can also be usedto treat other organs with examples such as the urinary bladder, liver,prostate, and uterus. In another embodiment, the MSD may be a structurethat is inserted within various locations of the gastrointestinal tractand expands against the internal walls of the selected alimentary organ.The force applied to the wall affects the vagal nerves branding into theorgan and affects the conduction. In particular embodiment, the MSD canbe permanent, biodegradable or digestible. The MSD can extend into theesophagus and intestinal tract if so required. In all of theaforementioned embodiments, the MSD can function as an electrode, orhave one or more discrete electrodes incorporated for monitoring,stimulation, or both. In all embodiments, the MSD can be activated orcoupled with electromagnetic or magnetic energy from an external source.The source may be directed coupled to the MSD or coupled wirelessly viainductive, capacitive, magnetic and other external energies.

The MSD technology and methods may also be used to treat certain typesof fecal incontinence by blocking afferent or efferent nerve conductionbetween the intestinal tract sphincters and the brain. Although thenerve of choice would again be the sacral nerve, other nerves may alsobe targeted for the treatment.

As previously disclosed, the MSD can also be designed to react with bodyfluids in order to generate therapeutic results. In this case, thegastric acids of the gastrointestinal tract can react with the MSD in atherapeutic fashion.

The MSD technology and methods can also be used to prevent vomiting andnausea by affecting the Vagal nerve conduction. This may be beneficialin the treatment of bulimia and self-induced vomiting. The MSD can alsobe used to block or desensitize the nerves and constrictor muscle withinthe throat. This would prevent or limit the ability of the person tocause self-induced vomiting. The procedure can be easily performed byinserting or injecting an MSD into the nerves or constrictor muscle viathe mouth or nasal sinus. The same type of MSD devices and methods canbe used to treat persistent or psycogenic coughing. Again, the MSD canbe permanent, temporary or biodegradable. In an alternative embodiment,the MSD tubular structures can be used to reduce nerve compression whenplace around the nerve and the MSD expands radially, the pressure isremoved from the nerve. Carpal tunnel syndrome may be treated with thismethod and devices.

As previously disclosed in the applications and patents that this patentclaims benefit to, the MSD may be connected to an electrical generator,incorporate an electrical generator, or be activated by an externalelectrical generator. For one skilled in the art, it is apparent thatother forms of activation or complementary therapies and technologiescan be implemented with the MSD and are also incorporated by referenceand claim benefit of the previously disclosed applications and patents.

Another debilitating neurologic disorder is palmar hyperhidrosis. Thisdisorder causes the sufferer to have sweaty palms. Current treatmentsare similar to the aforementioned disorders and include a surgicalprocedure called sympathectomy; cutting of the sympathetic nerve.Another method that is less invasive uses phenol to kill the nerve.Using MSD technology and methods and previously discussed, a permanentor temporary manipulation of the sympathetic nerve may be provebeneficial. Again, the preferred embodiment would include minimallyinvasive procedures and devices. The placement of the MSD could beguided by imaging technologies such as CT fluoroscopy. One target forimplantation on could be proximate of the sympathetic junction at thethird vertebra. The MSD can be in the form of a clip or a device thatimpinges or pinches the nerve to cause a block. If necessary theprocedure can be reversed by simply removing the MSD. Individualsympathetic nerve innervation crossing the second rib level be dividedand isolated with the MSD. The Kuntz nerves can be an isolated nervetarget for MSD treatment.

Other ailments that may benefits from the MSD technologies ability toblock, down-regulate neural activity, inhibit inflammatory processesinclude pancreatitis, colitis, irritable bowel syndrome, dyspepsia,sciatica, ileus, Crohn's disease, diabetes, dysfunctional valves andsphincters of the alimentary organs, and gastroesophageal reflux disease(GERD) as examples. The enteric nervous system, as whole or portionsthereof, may also be manipulated by the MSD technologies. The MSD canalso affect the neurologic function and secretion function of thepancreas, liver and gall bladder. In addition to providing therapeuticaffects, the MSD technologies may also protect other organs bypreventing antidromic responses or to block adverse side effects of thesignals from electrical-based neurostimulation, drugs, and othertreatments on proximate organs such as coronary, respiratory, adrenal,and others.

As mentioned previously, MSD technology can be used to compress thevascular to control bleeding or hemorrhaging. This is particularlyvaluable for the treatment of bloody noses. As shown in FIG. 2, the MSDcan be in a tubular form and similar to a vascular stent, placed intothe nasal and sinus passages, expanded (e.g. self-expanding,balloon-expanded) at the sight of bleeding and causing tamponade of thebleeding vascular tissue. The MSD can coatings such as drugs, minerals,gauze, fabric, lubricants, or other materials that assist in causinghemostasis. A tubular form would allow air passage through the MSD andmaintain patient comfort; however other forms can are anticipated. TheMSD can also be connected to an RF cautery generator to assist increating coagulation and hemostasis.

In addition, as FIG. 2 further illustrates and educates one skilled inthe art, the MSD devices and methods can also be used for rhinoplastyand septoplasty as well as to treat perforated septum's, sinusitis, andother nasal sinus obstructions. Further support for devices and methodssimilar to MSD is covered by Mische in the pending U.S. patentapplication Ser. No. 09/733,775 that claims the benefit of provisionalapplications with Ser. No. 60/169,778, 60/181,651 and 60/191,664, whichdiscloses devices and methods for the treatment and support of brokennoses and sinus cavities, and which all are hereby incorporated byreference herein.

The MSD technology and methods can treat other neurologic or physiologicdisorders such as Tourette's Syndrome, muscle spasms and contraction,nerve compression, nausea, tinnitus, vertigo, Meniere's Disease,Raynaud's Disease, Facial Blushing (erythrophobia), burning face(hyperpyrexia), rosacea, tardive dyskinesia, oropharyngeal and otherdysphagia, achalasia, sphincter contractions, pancreatitis, vomiting,persistent or psycogenic cough. The treatment of these diseases isillustrative and is not meant to be limiting. With the foregoingdetailed description of the present invention, it has been shown how theobjects of the invention have been attained in a preferred manner.Modifications and equivalents of disclosed concepts such as those whichmight readily occur to one skilled in the art are intended to beincluded in the scope of the claims which are appended hereto.

BRIEF DESCRIPTION OF THE DRAWINGS

Throughout the several views of the drawings several illustrativeembodiments of the invention are disclosed. It should be understood thatvarious modifications of the embodiments might be made without departingfrom the scope of the invention. Throughout the views identicalreference numerals depict equivalent structure wherein:

FIG. 1. is a schematic diagram of the head showing mechanical stressdevices implanted within brain tissue.

FIG. 2. is a schematic diagram of the head showing mechanical stressdevices implanted in the frontal sinus, lateral ventricle of brain, andbetween the skull and brain tissue;

FIG. 3. is a schematic diagram of the head showing the mechanical stressdevice delivery system;

FIG. 4. is a schematic diagram of the head showing the mechanical stressdevice delivery system;

FIG. 5. is a schematic diagram of the head showing the mechanical stressdevice delivery system;

FIG. 6. shows a variety of MSD designs;

FIG. 7. depicts an MSD, which is manually expanded contracted;

FIG. 8. depicts various MSD designs affecting the nerves of the urinarybladder;

FIG. 9. depicts various MSD designs affecting the nerves of the stomach;

FIGS. 10A, 10B, and 10C shows an MSD being advanced through the wall ofan organ and around a nerve on the organ.

FIG. 11. shows a variety of additional MSD designs.

DETAILED DESCRIPTION

The device and methods, which are similar to those discussed in thepatent application with Ser. No. 09/444,273 filed on Nov. 19, 1999 byMische entitled, “Mechanical Devices for the Treatment of Arrhythmias”which is incorporated by reference herein.

Throughout the description the term mechanical stress device MSD refersto a device that alters the electrical properties or chemical propertiesof physiologic tissues. The device may be made of metal such as Nitinolor Elgiloy and it may form an electrode for electrical stimulation. Oneor more electrodes may be associated with it. The MSD may incorporatefiber optics for therapeutic and diagnostic purposes. The device mayalso be made from a plastic or other non-metallic material. The MSD mayalso incorporate a covering of polymer or other materials. The MSD mayalso be a composition of different materials. The MSD may be smooth orhave cutting or abrasive surfaces. The MSD may have, but not limited to,other elements that protrude from the contour of the surfaces such asspindles, splines, ribs, points, hooks, wires, needles, strings, andrivets.

The MSD may be implanted for chronic use or for acute use. Biodegradablematerials that degrade or dissolve over time may be used to form theMSD. Various coatings may be applied to the MSD including, but notlimited to, thrombo-resistant materials, electrically conductive,non-conductive, thermo-luminescent, heparin, radioactive, orbiocompatible coatings. Drugs, chemicals, and biologics such asmorphine, dopamine, aspirin, lithium, Prozac, genetic materials, andgrowth factors can be applied to the MSD in order to facilitatetreatment. Other types of additives can be applied as required forspecific treatments.

Electrically conductive MSDs, or MSDs with electrode elements, may beused with companion pulse generators to deliver stimulation energy tothe tissues. This electrical therapy may be used alone or in combinationwith other therapies to treat the various disorders. Electricaltherapies may be supplied from implantable devices or they may becoupled directly to external generators. Coupling between the MSD andexternal generators can be achieved using technologies such asinductive, capacitive or microwave coupling as examples. The MSD mayalso be designed of geometries or materials that emit or absorbradioactive energies.

FIG. 1 is a schematic diagram showing several possible locations andgeometries for the mechanical stress device (MSD) within the brain 10. Amulti-element splined MSD 12 is positioned proximate to the thalamus 14.In this case, the treatment is for Parkinson's disease. A coil MSD 16 ispositioned proximate to the trigeminal nerve 18 for treatment oftrigeminal neuralgia. A wire form MSD 11 is positioned adjacent to thespinal cord 13.

FIG. 2. is a schematic diagram of the head showing 20 various locationsof MSDs of a tubular mesh form. An MSD 22 is located in the lateralventricle of the brain 24. Another MSD 26 is positioned between theskull 28 and the brain 24. Within the frontal sinus 21 an MSD 23 ispositioned. To one skilled in the art, it is obvious that this inventiveform of MSD in the nasal sinuses can be to treat symptoms of sinusitis,maintain passageways, treat deviated septums and other nasal sinusailments. The previously discussed balloon form of MSD can provide analternative or additional form of therapy within the same sinustreatment realm. In addition, heart rhythms may be affected by properplacement of an MSD within the nasal sinus. FIG. 3 and FIG. 4 should beconsidered together. Together the two figures show the deployment of anMSD.

FIG. 3 is a schematic diagram of a tubular mesh type MSD deliverysystem. The tubular catheter 32 delivers the tubular mesh MSD 34. Thefirst stage of implantation is navigation of the device to the selectedsite through the skull 36.

FIG. 4 shows the tubular mesh 42 expanding into position as it emergesfrom the lumen of the delivery catheter 44. In the self-expanding case,the tubular mesh has a predetermined maximum expandable diameter. Themesh can be made of a shape-memory material such as Nitinol so that whensubjected to body temperature the structure expands. With shape memorymaterials, the shape of the expanded device can be predetermined.Additionally, the device can be retrieved, repositioned, or removed byusing its shape memory characteristics. In general the MSD may be usedacutely or chronically depending on the disease state of the patient.

FIG. 5 shows an alternate balloon expanded MSD 52. In this alternateembodiment a balloon 54 may be used to expand the device within orproximate to selected tissues. In the balloon expandable case, theballoon may have a predetermined minimum or maximum diameter. Inaddition, the balloon shape can be made to provide proper placement andconformance of the device based on anatomical requirements and location.The balloon may be covered with electrically conductive material. Theballoon may be inflated via a syringe 56 and a pressure gauge 58. Forexample an electrode site 53 may be connected to a remote pulsegenerator (not shown) to stimulate or ablate the site. The stimulatormay activate the electrode either chronically or acutely.

FIG. 6 shows a variety of possible MSD shapes and geometries. A tubularmesh 62, a multi-element spline 64, a coil 66, a wire 68 are allacceptable shapes for the MSD although each shape may be specificallyadapted to a particular disease state. Other anticipated geometriesinclude clam shells, spherical shapes, conical shapes, screws, andrivets. Although the preferred embodiments consider expandablegeometries, alternate geometries can be constructed that retract,compress, collapse, crimp, contract, pinch, squeeze or elongate biologicand physiologic tissues as long as they provide one or more of thedesired mechanical, electrical or chemical effects on the selectedtissue. Delivery methods for the different possible geometries areanticipated, too.

FIG. 7 shows two states of a manually expandable MSD device 71. Thedevice consists of a coaxial shaft 72 and tube 73 arrangement. Attachedto the distal end of the shaft 72 and the tube 73 is a braided mesh tubeMSD 71. When the shaft 72 and tube 73 are moved opposite of the other bymanipulating the proximal ends, the MSD 71 expands 75 or contracts 76.In this case, the MSD 71 can be made of any structure that expands andcontracts such as a coil, splined-elements, etc. The various methods ofexpanding and contracting these structures are, but not limited to,push-pull, rotation, and balloon manipulation. In this type of device,direct connection to either an electrical generator, laser, ormonitoring system can be made. In addition, it be envisioned that adevice of similar nature be connected to a mechanical energy source,such as rotational or vibrational, in order to increase localizedstresses.

The MSD can also utilize devices such as a balloon catheter, expandingdevices, or wedges that impart stress or certain levels of localizedtrauma to selected tissues. The resultant stress and trauma affect thetissues so that current conduction in modified. It is envisioned thatany of these devices can be used alone or in conjunction with othertreatment modalities in order to provide the desired therapeutic result.

FIG. 8 show a diagram of the urinary bladder 80, its major nerves, andvarious designs of MSD's in place. The sacral nerve 81 and pudendalnerve 82 are shown being treated with various MSD devices. MSD 83 isplaced adjacent to the sacral nerve. MSD 84 is a substantially tubulardevice that is placed around the sacral nerve and impinges on it as itretracts in diameter. MSD 85 is a coiled structure that is placed aroundthe pudendal nerve and can retract onto the nerve as well act anelectrical inductor and receive RF energy from an external source. MSD86 is a solid structure that is inserted within the pudendal nervebundle. Like other MSD designs, this type of structure can be injectedwithin the nerve bundle for a more direct impact. Like other MSDembodiments, it can be permanent or biodegradable. MSD 87 is anexpandable form of design that is inserted within the nerve bundle. MSD88 is a form that is wrapped or place around the urethra and pudendalnerve. It can simultaneously treat urge and can also be used to supportthe urethra to treat other types or incontinence such as stressincontinence. MSD 89, in its implanted state, is a substantially tubulardevice that contracts and affects the external innervation of thebladder. It can also be activated by internal or external energysources. A similar type of geometry can be placed within the bladder andaffects the bladder innervation as it expands against the internalbladder wall.

In FIG. 9, the stomach 90 is shown at the junction with the esophaguswith its major vagal innervation; anterior vagal nerve bundle 91 andposterior vagal nerve bundle 92. MSD 93 is placed around the stomach 90and the nerve bundles (91 and 92) affecting the nerve conduction orproviding satiety, or both. Similar results are gained by MSD 94 whichimpinges on the stomach innervation and causes a mechanosensory affectwith mechanical forces that modifies the nerve conduction between thestomach and brain. This mechanical affect blocks or reduces theintensity of the “hunger signal” or creates the sense of satiety. Astructure similar to 94, albeit in an expanding state, can be placedwithin the stomach or other portions of the digestive tract in order totherapeutically impact the digestive tracts innervation and sensorypathways. MSD 95 is placed adjacent to a nerve bundle and projectsmechanical forces affecting nerve conduction. MSD 96 is a contractingtubular device place around a nerve bundle that creates a nerve block asit impinges on the nerve bundle. MSD 97 is a tubular coil structureplaced around the nerve bundle and, similar to MSD 85, can interact withRF energy sources. MSD 98 is placed within the nerve bundle. Anelectrical connection 99 is shown between MSD 96 and MSD 98. This isillustrative of the ability to use multiple and various MSD's designs ina treatment regimen, as well as to exploit a benefit by electricallyinterconnecting them.

FIGS. 10A, 10B, and 10C shows a sequence of placing an MSD device arounda nerve bundle on the surface of an organ. FIG. 10A shows a deliverydevice 101 loaded with an MSD 102. The delivery device has been advancedto either the internal or external wall of the organ 104. Nerve bundle103 is located on the opposite side of the organ wall 104. In FIG. 10B,MSD 102 has been pushed out of the delivery device 101, through theorgan wall 104 and around the nerve 103. FIG. 10B shows MSD 102 wrappedaround the nerve bundle 103 and partially imbedded within the organwall. In an alternative embodiment, the MSD 102 can also maintain aportion of itself on the wall surface of introduction. The MSD 102 canbe made of a preformed material that takes it shape from its inherentelastic or spring properties. Likewise, it can take its shape byutilizing shape memory materials or by mechanical deformation. Aspreviously mentioned, the MSD 102 may also be in the form of a suture, asolid device such as MSD 86, or other MSD designs previously discussedor anticipated. In a slight modification to this embodiment, instead ofbeing advanced through the organ wall 104 and around the nerve bundle103, the MSD 102 can be installed directly around the nerve bundle 103from the nerve bundle side of the organ wall 104.

FIG. 11 shows a variety of MSD designs including a cone (1), cylinder(2), screw (3), pointed rod (4), U-clamp (5), dart (6), tined rod (7),cylinder with bristles (8), random coil (9), parallel electrical circuit(10), series electrical circuit (11), multi-segment form (12), roundwasher form (13), and a 2 piece rivet form (14).

In general, the MSD will have a relaxed or minimum energy state. Howeverthe device or the implantation procedure should stretch or stress thedevice so that it applies a persistent force to the tissues to alterconduction in the strained tissues. In this sense the implanted MSD isnot in a fully relaxed state after implantation. In some instances theMSD will cause the tissues to yield or tear generating alteredconduction.

Preferably, the MSD is delivered in a minimally invasive procedure suchvia a catheter or other device. X-ray imaging, fluoroscopy, MRI, CATscan or other visualization means can be incorporated into theprocedural method. In general the devices maybe introduced withcannulas, catheters or over guidewires through naturally occurring bodylumens or surgically prepared entry sites. It should be apparent thatother surgical and non-surgical techniques can be used to place thedevices in the target tissue.

It should be apparent that various modifications might be made to thedevices and methods by one of ordinary skill in the art, withoutdeparting from the scope or spirit of the invention.

In another embodiment, MSD's may also be designed in order to optimizecoupling with external sources of electromagnetic energies via inductiveor capacitive coupling. These energies can be utilized to electricallyactivate the MSD in order to impart voltages and currents to tissues toaugment the mechanoelectric and or mechanochemical effects of the MSD.The MSD can be designed in such a fashion where it acts similarly to animplanted antenna. Likewise, the MSD may function primarily as anantenna with little, if any, mechanoelectric effects. The coupledelectrical energy to this MSD antenna can be directly imparted to thetissues adjacent to the implanted. The received energy may be used tocharge a circuit that is integrated into the MSD structure thatdischarges at a certain level, directing electrical energy to thedesired or adjacent tissue. For example, the circuit may consist ofresistors, capacitors, inductors, waveguides, amplifiers, diodes orother components that assist in producing the desired function andeffects. The circuit may consist of separate nodes for input and outputvoltages or it may have one node for both input and output. The MSD mayalso have a discrete antenna, antenna-circuitry or waveguide forreceiving or transmitting energy and/or information.

In another embodiment, the MSD may consist of circuitry that canautomatically treat the neurological defects by utilizing the electricalenergy generated by the physiologic tissues in which the MSD isimplanted. In the case of epilepsy, focal tissues generate errantcurrents that result in seizure activity. These affected focal tissuesare readily identified with standard CAT or MRI imaging systems and anMSD can then be implanted into these tissues. When the errant currentsare generated, these currents charge the circuitry in the MSD. When thecircuitry is charged to a predetermined level, it discharges back intothe affected focal tissues and resolves the errant currents. A RC timeconstant circuit can be utilized for this MSD version. Amplifiers,signal generators and other processing circuitry can be incorporatedinto an MSD in order to increase or modify the output.

In another embodiment, the MSD has a covering to increase the surfacearea of the device. The covering can encompass the entire device orselected portions and can be positioned on the outside or insidesurface. Such a covering can be made of polymers such as Teflon,polyethylene, polyurethane, nylon, biodegradable materials or otherpolymeric materials. The covering can also be made of a fine metal orpolymeric mesh. In all cases, the covering can be bonded to the surfaceof the MSD or applied as a loose sheath-type covering. The covering canhave therapeutic materials applied or incorporated into the coveringmaterial itself. Examples of the therapeutic materials include drugs,stem cells, heparin, biologic materials, biodegradable compounds,collagen, electrolytes, radiopaque compounds, radioactive compounds,radiation-activated substances, or other materials that enhance theclinical effects and/or procedures.

In another embodiment, the MSD may have a material that substantiallyfills its interior space. Such a material would prevent formation ofspaces or voids once an expandable MSD is placed. The materials may befibrous, gels, porous, foam or sponge-like and may be incorporated withpolymers, glass, metals, radioactive compounds, biologic tissues, drugs,or other suitable materials that may enhance clinical effective and/orprocedures. The materials would be flexible enough to allow expansion ofthe MSD and can be made of polymers, glass, metal, biologic tissues,drugs, or other suitable materials. Although not limited to, examples ofbiologic materials include stem cells, brain cells and matter, thalamictissues, and collagen.

The use of appropriate materials may also provide certain electricalproperties to the MSD that enable it to receive, store and/or transmitelectrical energy. The dielectric properties of these materials wouldprovide electrical capacitor properties and function to the MSD. Thisprovides the benefit of creating an electrical circuit that can receive,store and discharge energy from various sources. The source may beexternal generators that couple capacitively, inductively ormagnetically, RF energy from a predetermined portion of theelectromagnetic spectrum to the MSD. In addition, the source may be anelectrical generator connected by a wire or a cable to the MSD.

Another means of generating therapeutic electrical energy is to utilizegalvanic effects. Proper material selection and interaction withphysiologic fluids and tissues would result in galvanic currents orelectrochemical reactions being generated by the MSD. Generally,dissimilar metals or materials would be used in order to optimize thegeneration of galvanic currents. These currents could provide constanttherapeutic electrical energy levels to the desired tissues. This couldpotentially benefit patients suffering from Parkinson's, epilepsy, pain,depression, migraines, etc. The galvanic currents can also be used toenergize, activate, or charge circuits or batteries that providemonitoring, diagnostic or therapeutic effects. This technology couldalso be used for intravascular devices such as stents in order toprevent thrombosis or hyperplasia or to energize implantable sensors ormonitoring devices. Galvanic devices can also be used to treatperipheral pain, generate revascularization of myocardial tissues, treattumors, provide electrical potential for drug transport into tissues,treat endometriosis, or to power, energize, activate, operate or chargeother medical devices such as cardiac pacemakers, defibrillators orother electrical generator based systems.

In another embodiment, the MSD may be a structure that completely orpartially slices into tissue. The slicing action cleaves or separatesthe tissue physically breaking the electrical conduction paths. In thiscase, the MSD can reach complete or partial state of expansion. In thecase of complete expansion, the residual stress to the tissue would beapproaching zero, while the partial expansion would result in a combinedclinical effect via part mechanical stress and part slicing of tissue.

Additional methods of constructing MSD's include using three-dimensionalstructures such as wedges, slugs, clips, rivets, balls, screws, andother structures that impart stress to the tissues. Materials such asopen-cell polymers, gels, liquids, adhesives, foams can also be insertedor injected into tissue and tissue spaces in order to generate thedesired amount of stress. These types of material could also have theadditional benefit of being therapeutic agents or carriers fortherapeutic agents.

Another MSD structure can consist of a balloon that is positioned atdesired location, inflated within the tissue, and then detached and leftin an inflated state. Examples of inflation media can be fluids, gels,foams, pharmaceuticals, and curable resins.

Other embodiments of MSD composition include construction using magnetand magnetic materials that complement the localized effects of the MSDby controlling the electrical properties of the tissues using gradientsand fields. In the case where the MSD is composed of magnet materials,the magnetic field emanating from the magnetic materials would biaselectric fields within the tissues. This effect can control thedirection of current conduction within the tissues. In the case wherethe MSD is composed of magnetic materials that interact with magneticgradients and fields, an external magnet placed proximate to the headcan physically manipulate the MSD. Movement of the magnetic would causemovement of the MSD. The manipulation would result in dynamic stressesto the tissues adjacent to the MSD, thus affecting the electricalproperties of the tissues and potentially resolving seizures or tremors.

Other MSD can be built with an integrated circuit consisting of aresistor, capacitor, and an inductor. The inductor couples with theexternal electromagnetic energy and the resulting current generated inthe inductor charges the capacitor. Based on the RC time constant of thecircuit, the capacitor charges to a certain level and then dischargesdirectly to the desired tissues and the errant currents are disrupted bythis discharge. A combination of electromagnetic coupling and directconnection incorporates a generator with a transmission coil and aground connection made directly to the patient, providing a closed-loopcircuit. The ground connection can be made directly to the skin of thepatient using a clip or a grounding pad such as used duringelectrosurgical procedures. The pad may be applied to the patient withtape, bands or adhesives. The ground connection may also be implanted onor within tissue. External generators may be manually operated by thepatient or other person or may be automatically operated utilizingmonitoring systems that identify seizures or tremors and energize theMSD. Likewise, automatic circuitry such as the aforementioned RC-timingcircuit can be used. The generators may also be programmed to energizeat a certain predetermined sequence, rate and level. In the treatment ofmania, depression, schizophrenia or similar disorders, the generator mayprovide a constant output to maintain a consistent state of electricalcondition of the tissues. For convenience, the external generators maybe attached directly to the head or incorporated into a hat, helmet, orband. Alternately, the transmission coil separately may be attacheddirectly to the head or incorporated into a hat, helmet, scarf or band.The coil may encompass the entire head or specific portions in order toattain desired coupling with the MSD. In addition, strain gaugetechnology can be incorporated that can measure and correlate the amountof mechanical stress and strain imparted to tissues or stress andstrains imparted to the device by tissues and active organs such asvessels, hearts, valves, and other organs and tissues. Such data can beused to provide a feedback means by which to control the MSD in order toprovide treatment as necessary based on the physiologic response oractivation.

Likewise, as mentioned previously, the electrical energy inherent inphysiologic tissue may also be the source that energizes the circuit.Again, it should be noted that various modifications might be made tothe devices and methods by one of ordinary skill in the art, withoutdeparting from the scope of the invention.

What is claimed:
 1. A method for treating obesity comprising: surgicallyaccessing a vagal nerve on a stomach; positioning a mechanical deviceproximate to the vagal nerve on the exterior of the stomach with adelivery device; detaching the mechanical device from a delivery device;and applying a mechanical force to the vagal nerve directly with themechanical device to modify vagal nerve conduction.
 2. The method ofclaim 1, wherein the mechanical device is biodegradable.
 3. The methodof claim 1, wherein the mechanical device is placed by a laproscopicsurgical procedure.
 4. The method of claim 1, wherein the mechanicaldevice is an adjustable balloon.
 5. The method of claim 1, wherein themechanical device is energized by an electrical generator.
 6. The methodof claim 1, wherein the mechanical device is an injectable substance. 7.The method of claim 1, wherein the mechanical device is introduced fromwithin the stomach.
 8. The method of claim 1, wherein the mechanicalforce is expansion.
 9. The method of claim 1, wherein the mechanicalforce is contraction.
 10. The method of claim 1, wherein the mechanicaldevice is permanently implanted.
 11. The method of claim 1, wherein themechanical device is temporarily implanted and later removed.
 12. Themethod of claim 1, wherein detaching the mechanical device from thedelivery device comprises unscrewing the mechanical device from thedelivery device.
 13. The method of claim 1, wherein detaching themechanical device from the delivery device comprises detaching themechanical device from the delivery device with a detent release. 14.The method of claim 1, wherein detaching the mechanical device from thedelivery device comprises detaching the mechanical device from thedelivery device with a release of compression.